US20070162135A1 - Mechanical apparatus and method for artificial disc replacement - Google Patents

Abstract

The present invention relates to a device and method which may be used to reinforce the native annulus during spinal surgery. The device is a catheter based device which is placed into the inter-vertebral space following discectomy performed by either traditional surgical or endoscopic approaches. The distal end of the catheter is comprised of an expansile loop which may be increased in diameter by advancement of a portion of the catheter via its proximal end, such proximal end remaining external to the body. The expansile loop may be formed such that when the loop is diametrically contracted the loop feeds into its other end, similar to a snake eating its own tail. Stabilization of the outer portion of the loop and pulling out the inner portion will thereby increase the overall diameter of the loop while maintaining it as a closed loop or torus. The expansile loop can use an attachment means to secure it to substantially healthy tissues of the annulus, nucleus, or endplates. The present invention comprises four embodiments and can be used to 1) facilitate disk fusing, 2) perform an artificial replacement of the nucleus, 3) perform an artificial replacement of the annulus, or 4, perform an artificial replacement of both the nucleus and annulus.

Description

CROSS-REFERENCES
• The present application is a continuation-in-part of patent application Ser. No. 11/153,776 filed on Jun. 15, 2005, Ser. No. 11/173,034 filed on Jul. 1, 2005, Ser. No. 11/272,299 filed on Nov. 14, 2005 and 11/359,335 filed on Feb. 22, 2006. These applications are incorporated herein by this reference.
FIELD OF THE INVENTION
• The present invention generally relates to devices and methods for the repair of inter-vertebral discs. More, specifically, the present invention relates to devices and methods for the treatment of spinal disorders associated with the nucleus, annulus and inter-vertebral disc.
BACKGROUND OF THE INVENTION
• Inter-vertebral disc disease is a major worldwide health problem. In the United States alone almost 700,000 spine procedures are performed each year and the total cost of treatment of back pain exceeds $30 billion. Age related changes in the disc include diminished water content in the nucleus and increased collagen content by the 4^thdecade of life. Loss of water binding by the nucleus results in more compressive loading of the annulus. This renders the annulus more susceptible to delamination and damage. Damage to the annulus, in turn, accelerates disc degeneration and degeneration of surrounding tissues such as the facet joints.
• The two most common spinal surgical procedures performed are discectomy and spinal fusion. These procedures only address the symptom of lower back pain. Both procedures actually worsen the overall condition of the affected disc and the adjacent discs. A better solution would be implantation of an artificial disc for treatment of the lower back pain and to restore the normal anatomy and function of the diseased disc.
• The concept of a disc prosthesis dates back to a French patent by van Steenbrugghe in 1956. 17 years later, Urbaniak reported the first disc prosthesis implanted in animals. Since this time, numerous prior art devises for disc replacement have been proposed and tested. These are generally divided into devices for artificial total disc replacement or artificial nucleus replacement. The devises proposed for artificial total disc replacement, such as those developed by Kostuik, that generally involve some flexible central component attached to metallic endplates which may be affixed to the adjacent vertebrae. The flexible component may be in the form of a spring or alternatively a polyethylene core (Marnay). The most widely implanted total artificial disc to date is the Link SB Charite disc which is composed of a biconvex ultra high molecular weight polyethylene spacer interfaced with two endplates made of cobalt-chromium-molybdenum alloy. Over 2000 of these have been implanted with good results. However device failure has been reported along with dislocation and migration. The Charite disc also requires an extensive surgical dissection via an anterior approach.
• The approach of artificial nucleus replacement has several obvious advantages over artificial total disc replacement. By replacing only the nucleus, it preserves the remaining disc structures such as the annulus and endplates and preserves their function. Because the annulus and endplates are left intact, the surgical procedure is much simpler and operative time is less. Several nuclear prostheses can be place via a minimally invasive endoscopic approach. The nucleus implant in widest use today is the one developed by Raymedica (Bloomington, Minn.) which consists of a hydrogel core constrained in a woven polyethylene jacket. The pellet shaped hydrogel core is compressed and dehydrated to minimize size prior to placement. Upon implantation the hydrogel begins to absorb fluid and expand. The flexible but inelastic jacket permits the hydrogel to deform and reform in response to compressive forces yet constrain the horizontal and vertical expansion (see U.S. Pat. Nos. 4,904,260 and 4,772,287 to Ray). Other types of nuclear replacement have been described which include either an expansive hydrogel or polymer to provide for disc separation and relieve compressive load on the other disc components (see U.S. Pat. No. 5,192,326 to Boa). Major limitations of nuclear prostheses are that they can only be used in patients in whom disc degeneration is at an early stage because they require the presence of a competent natural annulus. In discs at later stages of degeneration the annulus is often torn, flattened and/or delaminated and may not be strong enough to provide the needed constraint. Additionally, placement of the artificial nucleus often requires access through the annulus. This leaves behind a defect in the annulus through which the artificial nucleus may eventually extrude compressing adjacent structures. What is clearly needed is a replacement or reinforcement for the natural annulus which may be used in conjunction with these various nuclear replacement devices.
• Several annular repair or reinforcement devices have been previously described. These include the annulus reinforcing band described by U.S. Pat. No. 6,712,853 to Kuslich, which describes an expansile band pressurized with bone graft material or like, expanding the band. U.S. Pat. No. 6,883,520B2 to Lambrecht et al, describes a device and method for constraining a disc herniation utilizing an anchor and membrane to close the annular defect. U.S. patent application Ser. No. 10/676,868 to Slivka et al. describes a spinal disc defect repair method. U.S. Pat. No. 6,806,595 B2 to Keith et al. describes disc reinforcement by implantation of reinforcement members around the annulus of the disc. U.S. Pat. No. 6,592,625 B2 to Cauthen describes a collapsible patch put through an aperture in the sub-annular space. U.S. patent application Ser. No. 10/873,899 to Milbocker et al. describes injection of in situ polymerizing fluid for repair of a weakened annulus fibrosis or replacement or augmentation of the disc nucleus.
• Each of these prior art references describes devices or methods utilized for repair of at least a portion of the diseased annulus. What is clearly needed is an improved spinal disc device and method capable of reinforcing the entire annulus circumferentially. In addition what is clearly needed is a spinal disc device and method which may be easily placed into the inter-vertebral space and made to conform to this space. What is clearly needed is an improved spinal disc device and method capable of reinforcing the entire annulus that may be utilized either in conjunction with an artificial nucleus pulposis or may be used as a reinforcement for the annulus fibrosis and as an artificial nucleus pulposis.
SUMMARY OF THE INVENTION
• The present invention addresses this need by providing improved spinal disc device and methods for the treatment of inter-vertebral disc disease. The improved device and methods of the present invention specifically address disc related pain but may have other significant applications not specifically mentioned herein. For purposes of illustration only, and without limitation, the present invention is discussed in detail with reference to the treatment of damaged discs of the adult human spinal column.
• As will become apparent from the following detailed description, the improved spinal disc device and methods of the present invention may reduce if not eliminate back pain while maintaining near normal anatomical motion. The present invention relates to devices and methods which may be used to reinforce or replace the native annulus, replace the native nucleus, replace both the annulus and nucleus or facilitate fusion of adjacent vertebrae. The devices of the present invention are particularly well suited for minimally invasive methods of implantation.
• The spinal disc device is a catheter based device which is placed into the inter-vertebral space following discectomy performed by either traditional surgical or endoscopic approaches. The distal end of the catheter is comprised of an expansile loop or mesh which may be increased in diameter by either advancement or retraction of a control element comprising a flexible portion of the catheter which may be manipulated by its proximal end, such proximal end remaining external to the body. The expansile loop or mesh may be formed of a woven, knitted, embroidered or braided material and may be made of Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluroethylene (e-PTFE), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) commercially available as Spectra™ or Dyneema™, as well as other high tensile strength materials such as Vectran™, Kevlar™, natural or artificially produced silk and commercially available suture materials used in a variety of surgical procedures. Alternatively the expansile loop or mesh portion of the catheter may be made of a biodegradable or bioabsorbable material such as resorbable collagen, LPLA (poly(l-lactide)), DLPLA (poly(dl-lactide)), LPLA-DLPLA, PGA (polyglycolide), PGA-LPLA or PGA-DLPLA, polylactic acid and polyglycolic acid which is broken down and bioabsorbed by the patient over a period of time. Alternatively the expansile portion of the catheter may be formed from metallic materials, for example, stainless steel, elgiloy, Nitinol, or other biocompatible metals. Further, it is anticipated that the expansile loop portion of the device could be made from a flattened tubular knit, weave, mesh or foam structure.
• The expansile loop may be formed such that when the loop is diametrically contracted one end of the loop feeds into its other end, similar to a snake eating its own tail. Alternatively, the expansile loop may be formed such that when it is diametrically contracted it is in the shape of a toroid invaginating into itself. Stabilization of the outer portion of the loop and pulling out the inner portion will thereby increase the overall diameter of the loop while maintaining it as a substantially closed loop or toroid.
• In one embodiment, the present invention consists of a device and method, whereby the present invention is first delivered and expanded within the vertebral space to the limits of the inner portion of the native annulus to reinforce or artificially replace the native annulus.
• In another embodiment, the present invention consists of a device and method, whereby the present invention is first delivered and expanded within the vertebral space to the limits of the inner portion of the native annulus and then an injection of polymeric or hydrogel or like material is conducted to reinforce or artificially replace the native annulus.
• In another embodiment, the present invention consists of a device and method, whereby the present invention is first delivered and expanded within the vertebral space to the limits of the inner portion of the native annulus and then the inner portion of the present invention is centrally expanded to the limits of an artificial nucleus concurrently or previously placed within the inter-vertebral space.
• In another embodiment, the present invention consists of a device and method, whereby the present invention is first delivered within the vertebral space and into the area of the nucleus, which may have been previously removed, and expanded to the limits of the outer portion of the area of the native nucleus and then injected with a polymer or hydrogel or like material conducted to reinforce or artificially replace the native nucleus.
• In another embodiment, the present invention consists of a device and method, whereby the present invention is first delivered within the vertebral space and expanded within the vertebral space to the limits of the outer portion of the native annulus and then an injection of polymeric or hydrogel material is conducted to reinforce or artificially replace the native annulus. Then the present invention is delivered into the nucleus area and expanded to the limits of the outer portion of the native nucleus or an artificial nucleus concurrently placed and then an injection of polymeric or hydrogel material is conducted to reinforce or artificially replace or reinforce the nucleus.
• In another embodiment, the present invention consists of a device and method, whereby the present invention is first delivered and expanded within the vertebral space and expanded inward from the outer limits of the annulus to the point where essentially no central hole remains in the toroid and a polymeric or hydrogel or like material is injected into the expanded mesh.
• In another embodiment, the present invention consists of a device and method, whereby the present invention is delivered and expanded within the vertebral space and then an injection of a bone graft material, polymeric bone graft compound, or material inducing or promoting the growth of bone such as, but not limited to growth factors, BMP or like is conducted in order to facilitate the fusion of an adjacent vertebrae.
• In another embodiment, the present invention consists of a device and method, whereby the present invention is delivered and expanded within the vertebral space surrounding previously or concurrently placed bone graft material, polymeric bone graft compound, or material inducing or promoting the growth of bone such as, but not limited to growth factors, BMP or like in order to facilitate the fusion of an adjacent vertebrae.
• The present invention and variations of its embodiments is summarized herein. Additional details of the present invention and embodiments of the present invention may be found in the Detailed Description of the Preferred Embodiments and Claims below. These and other features, aspects and advantages of the present invention will become better understood with reference to the following descriptions and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a cross-section view of one embodiment of the present invention with the control element attached to the interior distal end of the expansile loop and in a contracted delivery configuration.
• FIG. 2 is a cross-sectional of one embodiment of the present invention with the control element attached to the interior distal end of the expansile loop and with the sheath retracted and the expansile loop exposed.
• FIG. 3 is a cross-section view of one embodiment of the present invention with the control element attached to the interior distal end of the expansile loop and with the expansile in an expanded configuration.
• FIG. 4 is a cross-section of the one embodiment of the present invention with the control element attached to the interior distal end of the expansile loop and with the expansile loop in an expanded and the inner circumference of the expansile loop in a contracted configuration.
• FIG. 5 is a magnified cross-section view fromFIG. 4 of the present invention with the control element attached to the interior distal end of the expansile loop and showing the controlling end of the expansile loop.
• FIG. 6 is a cross-section view of another embodiment of the present invention with the control element exiting the sidewall of the outer section of the expansile loop and releasably connecting to the proximal portion of the outer section of the expansile loop and with the expansile loop shown in a contracted delivery configuration.
• FIG. 7 is a cross-sectional view of another embodiment of the present invention with the sheath retracted and the expansile loop exposed.
• FIG. 8 is a cross-section view of the embodiment ofFIG. 1 with the expansile loop in an expanded configuration.
• FIG. 9 is a magnified cross-section view fromFIG. 8 of the present invention showing the controlling end of the expansile loop.
• FIG. 10 is a cross-section view of another embodiment of the present invention with two control elements and in a contracted delivery configuration.
• FIG. 11 is a cross-sectional of another embodiment of the present invention with two control elements and with the sheath retracted and the expansile loop exposed.
• FIG. 12 is a cross-section view of another embodiment of the present invention with two control elements and with the expansile loop in an expanded configuration.
• FIG. 13 is a cross-section of another embodiment of the present invention with two control elements and with the expansile loop in an expanded and the inner circumference of the expansile loop in a contracted configuration.
• FIG. 14 is top view cross-section view of a spinal body (vertebrae) showing the posterolateral access tube advanced into the inter-vertebral space.
• FIG. 15 is a top view cross-section view of a spinal body (vertebrae) with one of the embodiments of the present invention being positioned within the inter-vertebral space of the spinal body (vertebrae).
• FIG. 16 is a top view cross-section of a spinal body (vertebrae) with one of the embodiments of the present invention expanded and surrounding the nucleus section of the spinal body (vertebrae).
• FIG. 17 is top view cross-section of a spinal body (vertebrae) with one of the embodiments of the present invention's outside diameter expanded and the inside diameter contracted within the inter-vertebral space of the spinal body (vertebrae).
• FIG. 18 is a cross-section dimensional view of the expansile loop in a partially expanded configuration with a diameter D and a height H.
• FIG. 19 is a cross-sectional dimensional view of the expansile loop in an expanded configuration with the diameter increasing +D and the height increasing +H.
• FIG. 20 is a cross-section view of another embodiment of the present invention with the expansile loop in an invaginated configuration (whereby a portion of the expansile loop is bent back and entering itself) with the expansile loop in a partially expanded configuration.
• FIG. 21 is a cross-sectional view of additional feature of the present invention with an inner catheter or control element having a plurality of holes for delivery and injection of biomaterials.
• FIG. 22 is a perspective view of an element of the present invention whereby locking elements on the distal end of the expansile interior loop are engaged to the expansile outer loop.
• FIG. 23 is a cross sectional view of the attachment means in the from of a suture and demonstrating a suture delivery system already advanced through an access tube and utilizing non-absorbable or re-absorbable sutures to attach the contracted configuration of the expansile mesh to the inner wall of the annulus at multiple points.
• FIG. 24 shows a cross sectional view of the attachment means in the form of a staple or helicoil with a delivery system already advanced through the access tube and utilizing non-absorbable or re-absorbable stables or helicoil mechanism to secure the expanded expansile mesh to the inner wall of the annulus at multiple points. Also shown are non-absorbable or re-absorbable stables or helicoils used to attach the expanded expansile mesh to the outer wall of an artificial nucleus at multiple points.
• FIG. 25 shows a cross sectional view of the expansile mesh contained within a vertebral bone structure with the mesh attached to the bone structure by means of screws or anchors.
• FIG. 26 is a top view cross-section view of a spinal body (vertebrae) with one of the embodiments of the present invention being positioned within the inter-vertebral space of the spinal body (vertebrae) for delivering a biomaterial or bone chips inside the expansile mesh.
• FIG. 27 is a top view cross-section of a spinal body (vertebrae) with one of the embodiments of the present invention expanded and surrounding the portion of the spinal body (vertebrae) where the nucleus has been previously removed.
• FIG. 28 is top view cross-section of a spinal body (vertebrae) with one of the embodiments of the present invention's outside diameter expanded and the inside diameter contracted within a delivery probe being inserting through the and advanced towards the inside of the expansile mesh.
• FIG. 29 is top view cross-section of a spinal body (vertebrae) with one of the embodiments of the present invention's outside diameter expanded and the inside diameter contracted within the inter-vertebral space of the spinal body (vertebrae), a delivery probe inserted through the expansile mesh whereby a biomaterial or bone chips are being delivered to the area inside the expansile mesh.
• FIG. 30 is a section taken fromFIG. 29 showing the expasile mesh having an original non-disturbed cross-pattern configuration.
• FIG. 31 is a section taken fromFIG. 29 showing the capability of the expansile mesh to flex open and allow the inserting of a delivery probe.
• FIG. 32 is top view cross-section of a spinal body (vertebrae) wherein one of the embodiments of the present invention's includes a bone block delivery apparatus having a shaft that is coaxially engaged with a first tubular member and a second tubular member, further wherein the shaft member has a terminal end with an attachment means temporally engaged with a bone block that is enclosed within the present invention expansile loop in a contracted configuration.
• FIG. 33 is top view cross-section of a spinal body (vertebrae) wherein one of the embodiments of the present invention's includes a bone block delivery apparatus having a shaft that is coaxially engaged with a first tubular member and a second tubular member, further wherein the shaft member has a terminal end with an attachment means temporarily engaged to a bone block and enclosed within the present invention expansile loop in a contracted configuration and being positioned within the inter-vertebral space.
• FIG. 34 is top view cross-section of a spinal body (vertebrae) wherein one of the embodiments of the present invention's includes a bone block delivery apparatus having a shaft that is coaxially engaged with a first tubular member and a second tubular member, further wherein the shaft member has a terminal end with an attachment means temporarily engaged to a bone block and enclosed within the present invention expansile loop in a circumferentially expanded configuration while positioned within the inter-vertebral space.
• FIG. 35 is top view cross-section of a spinal body (vertebrae) wherein one of the embodiments of the present invention's includes a bone block delivery apparatus having a shaft that is coaxially engaged with a first tubular member and a second tubular member, further wherein the shaft member has a terminal end with an attachment means disengaged from a bone block that is enclosed within the present invention expansile loop in a expanded configuration while positioned within the inter-vertebral space.
• FIG. 36 is top view cross-section of a spinal body (vertebrae) wherein one of the embodiments of the present invention's wherein the shaft (shown retracted) or other instrument (not shown) urges the bone block to move from a vertical position to a horizontal along the anterior wall of the annulus.
• FIG. 37 is top view cross-section of a spinal body (vertebrae) with one of the embodiments of the present invention's includes a bone block delivery apparatus that delivers a plurality of bone chips or materials to the inter-vertebral space.
• FIG. 38 is a top cross-section view of a spinal body (vertebrae) with one of the embodiments of the present invention having a locking strap type control element and expanded within the vertebral space.
• FIG. 39 is a side cross-section view of a spinal body (vertebrae) with one of the embodiments of the present invention having a locking strap type control element and showing a resulting configuration which includes a waist with a decreased diameter (concavo-concave configuration).
• FIG. 40 is a perspective view of one type of locking strap control element of the present invention comprised of locking head attached to an elongated strap.
• FIG. 41 is a magnified perspective view of one type of locking strap control element of the present invention comprised of locking head attached to an elongated strap body and further detailing the locking gear rack and head with internal lumen and ratchet tab or pall.
• FIG. 42 is a cross-sectional side view of one type of locking strap control element of the present invention comprised of locking head attached to an elongated strap, and showing the elongated strap inserted within the lumen of the head forming a loop and whereby the ratchet tab is engaged to one of the teeth of the locking gear rack.
• FIG. 43 is a cross-section taken fromFIG. 41 whereby the section plane extends through the ratchet tab or pall.
• FIG. 44 is a cross-section fromFIG. 41 whereby the section plane extends along one side of the ratchet tab or pall.
• FIG. 45 is a perspective view of a second type of locking strap control element of the present invention comprised of an elongated strap with a non-locking head and designed to cooperate with a locking mechanism.
• FIG. 46 is a magnified top perspective view of a second type of locking strap control element of the present invention comprised of a non-locking head attached to an elongated strap and further detailing the locking gear rack and the head with a substantially circular lumen.
• FIG. 47 is a magnified side perspective view of a second type of locking strap control element of the present invention comprised of a non-locking head attached to an elongated strap and further detailing a side view of the locking gear teeth and the substantially circular lumen in the head.
• FIG. 48 is a side cross-sectional view of the locking mechanism for the second type of locking strap control element of the present invention.
• FIG. 49 is a front view of the locking mechanism for the second type of locking strap control element of the present invention.
• FIG. 50 is an angled side view of the locking mechanism for the second type of locking strap control element of the present invention.
• FIG. 51 is a side cross-sectional view of the locking mechanism for the second type of locking strap control element of the present invention showing a section plane across the ratchet tab.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Oneembodiment10,11 of the spinal disc device, as shown inFIGS. 1-5, consists of anelongated probe15, with aproximal end17 and adistal end16. Referring toFIGS. 1 and 2, is can be seen that theelongated probe15 is constructed from at least two elements, a flexible innercatheter control element19, and a stifferouter catheter element12. The innercatheter control element19 is slideably located within theouter catheter element12. At theproximal end17 ofelongated probe15, the innercatheter control element19 exits from theouter catheter element12, and can be advanced or retracted causing thedistal end20 of the innercatheter control element19 to move in or out of thedistal end13 of theouter catheter element12. Near thedistal end16 of theelongated probe15, is situated an expansile, braided, woven or embroideredtubular loop24 in a contracted or delivery configuration (FIG. 1). The innercatheter control element19 enters theexpansile loop24 near thedistal end13 of theouter catheter element12 and slideably resides within theexpansile loop24. Thedistal end22 of theexpansile loop24 is fed into theproximal end23, of theexpansile loop24 in a manner similar to a snake eating its own tail. This results in anexpansile loop24 with an inner section and outer section as shown inFIGS. 1 and 2. A coveringretractable sheath18 is placed over theelongated probe15 to hold it in a constrained condition for delivery into the vertebral disc. After thesheath18 is retracted, theexpansile loop24 may be increased in circumferential diameter by withdrawing thedistal end22 of theexpansile loop24 from theproximal end23 of the outer expansile loop24 (FIG. 3). In this configuration, a substantially continuousinterior chamber28 is now defined within the expandedexpansile loop25. Theouter catheter element12 terminates at itsdistal end13 and is removably attached to theproximal end23 of the outer section of the expandedexpansile loop25. The innercatheter control element19, in the form of a filament, guidewire or flexible tube, slideably extends from theproximal end17 of the catheter orprobe15, through theouter catheter element12, and exiting the outer catheter element at itsdistal end13. The inner catheter element then enters the inside of the outer section of the expansile loop at itsproximal end23. The innercatheter control element19 may be looped one, less than one, or more than one time within theexpansile loop24,25 between the inner and outer portions of the loop prior to theinner catheter element19 or control element terminating within theexpansile loop24,25 at itsdistal end22,26. The innercatheter control element19 is then attached to theexpansile loop24,25 at thedistal end22,26 of the inner section of theexpansile loop24,25.
• The inner catheter control element can be made of a flexible yet longitudinally incompressible material such as, but not limited to, a stainless steel or Nitinol wire of 0.010″-0.040″ diameter. Slidably advancing theinner catheter element19 through theouter catheter element12 while holding the proximal portion of the outer section of theexpansile loop23,27 in place will result in the inner section of theexpansile loop24,25 pulling out of the outer section of theexpansile loop24,25. This will result in the overall diametric expansion of theexpansile loop24,25. As shown inFIG. 4, once expansion of the outer circumference of theexpansile loop25 is achieved and fixed, pulling out the innercatheter control element19 while holding theouter section27 of theexpansile loop25 fixed, contracts the inner circumference of theexpansile loop25 while expanding its height. Expansion of theexpansile loop25 into the vertebral space is achieved by the spring nature of the expansile loop's24,25 material construction or by advancing the innercatheter control element19 while holding the proximal outer section of theexpansile loop23 fixed. Next, pulling on the innercatheter control element19 while holding the proximalouter section27 of theexpansile loop25 fixed, the interior circumference of theexpansile loop25 contracts toward the center of theexpansile loop25 while the height of theexpansile loop25 increases.
• FIG. 5 is a magnified cross-section view fromFIG. 4 of this present invention embodiment with the control element attached to the interiordistal end26 of theexpansile loop25. This Figure shows the controlling end of theexpansile loop25 and the physical relationship between thedistal end20 of theinner catheter19, distal26 andproximal end27 of theexpansile loop25, andouter catheter element12.
• Theouter catheter element12 used for delivery of theexpansile loop24 should be sufficiently stiff to allow retraction of the innercatheter control element19 without collapse or kinking. The innercatheter control element19 must be sufficiently flexible to circle around theexpansile loop24 and attains a relatively small radius without kinking yet have sufficient tensile strength to resist breakage when pulled from its proximal sections. Theouter catheter element12 can be fabricated from polymeric materials including, but not limited to, Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluro-ethylene (e-PTFE), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE), or metallic materials, including but not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others that have sufficient kink resistance and tensile strength. The innercatheter control element19 can be manufactured from Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluro-ethylene (e-PTFE), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) or from metallic materials including, but not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. The elements manufactured from metallic materials have a diameter from 0.001″ to 0.020″ and preferably from 0.004″ to 0.010″. The elements manufactured from polymeric materials have a diameter from 0.005″ to 0.040″ and a preferred diameter from 0.010″ to 0.020″.
• Theexpansile loop24,25 is fabricated as a knit, weave or braid and can be constructed from non-degradable materials. Suitable non-degradable materials for theexpansile loop24,25, include, but are not limited to, Nylon, Dacron, synthetic polyamide,_polypropylene, expanded polytetrafluroethylene (e-PTFE), polyetheretherketone (PEEK), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) commercially available as Spectral or Dyneema™, as well as other high tensile strength materials such as Vectran™, Kevlar™, natural or artificially produced silk and commercially available suture materials used in a variety of surgical procedures. Theexpansile loop24,25 fabricated as a weave or braid and can be constructed from biodegradable or bioabsorbable materials. Suitable biodegradable and bioabsorbable materials for theexpansile loop24,25 include, but are not limited to, resorbable collagen, LPLA (poly(l-lactide)), DLPLA (poly(dl-lactide)), LPLA-DLPLA, PGA (polyglycolide), PGA-LPLA or PGA-DLPLA, and biodegradable sutures made from polylactic acid and polyglycolic acid.
• In addition, for some embodiments, suitable metallic materials for theexpansile loop24,25 may be used that include, but are not limited to, stainless steel, cobalt-chrome alloy, titanium, titanium alloy, or nickel-titanium shape memory alloys, among others. It is further contemplated that the metallic mesh can be interwoven with non-resorbable polymers such as nylon fibers, polypropylene fibers, carbon fibers and polyethylene fibers, among others, to form a metal-polymer composite weave. Further examples of suitable non-resorbable materials include DACRON and GORE-TEX. One feature of theexpansile loop24,25 is that it needs to have pore sizes or openings that are small enough to hold the filling material or nucleus from extruding out and large enough to maintain flexibility and expansion characteristics.
• In another embodiment thedistal end13 of theouter catheter element12 resides around the innercatheter control element19. Theouter catheter element12 is held in a constant relationship or releasably affixed to theproximal end23 of the outer section of theexpansile loop24. In this embodiment the innercatheter control element19 is in the form of a very flexible element which enters the proximal opening in the outside section of theexpansile loop23, loops one, less than one or more than one time around the inside of the outside section of theexpansile loop24 and terminates attaching at thedistal end22 of the inside section of theexpansile loop24. The direction of rotation of the flexible control element19 (measured from distal end of thecontrol element20 to theproximal end21 is in the opposite rotational direction as the direction of rotation of the inside section of theexpansile loop24, as it enters and loops around the outside section of theexpansile loop24. Upon retraction of theproximal end21 of the innercatheter control element19, back out of theouter catheter element12, thedistal end13 of theouter catheter element12 stabilizes and holds theouter section23 of theexpansile loop24 in place while theinner section22 of theexpansile loop24 is pulled out of the outer section, resulting in an increase in the diameter of theexpansile loop24. Once the expandedexpansile loop25 has reached its maximum diameter, determined either by the confines of the space into which it is expanding or by the exit point of the control filament through theproximal end27 of the expandedexpansile loop25, continued retraction of the innercatheter control element19 will result in the innercatheter control element19 producing tension on the inner circumference of the expandedexpansile loop25. The inner circumference of the expandedexpansile loop25 will contract towards the middle of the expandedexpansile loop25 and the expanded expansile loop's25 height will increase. Due to the woven, braided or embroidered nature of the tubularexpansile loop24,25, the expandedexpansile loop25, will remain generally in the shape of a toroid both upon its circumferential expansion and its central contraction.
• Anadditional embodiment39,40 of the expansile loop device used for repair or replacement of the annulus fibrosis of the spine can be understood by referring toFIGS. 6-9. As shown inFIGS. 6-8, the innercatheter control element19 is looped around and exits through the wall of the outer section of the expansile braided, woven or embroideredloop24 near the attachment of theouter catheter element12 to theproximal end23 of the outer section of theexpansile loop24. The innercatheter control element19 is then affixed to theouter catheter element12, at this point using either a knot or a releasable or removable junction or passes proximally through theouter catheter element12. A coveringretractable sheath18 is placed over theelongated probe15 to hold it in a constrained condition for delivery into the vertebral disc. After thesheath18 is retracted, a “snare” or loop is formed by the proximal portion of the innercatheter control element19 being slideably located within theouter catheter element12 and theexpansile loop24. If the innercatheter control element19 is of sufficient stiffness, for example but not limited to, a metallic guidewire of 0.010″-0.040″ diameter, the snare and theexpansile loop24 may be opened by advancing theproximal portion21 of the innercatheter control element19 while holding theouter catheter element12 and the proximal end of theexpansile loop23 in place. This opening of the circumference of the snare formed by the innercatheter control element19 will result in an expansion of the circumference of theexpansile loop24 as the inner portion of theexpansile loop24 pulls out of its outer portion. Once the limits of expansion of the expandedexpansile loop25 have been reached, the innercatheter control element19 may be detached at the junction or connection of theouter catheter12 and the proximal end of the expandedexpansile loop27 and slideably retracted out of the expandedexpansile loop25 leaving behind a circumferentially expandedexpansile loop25.
• In an alternative embodiment of the present invention for annular repair or replacement, the innercatheter control element19 is run inside of theexpansile loop24,25 which is looped and exits first the distal end of the inner section of the braided, woven or embroideredloop22,26 and then exits through the wall of the outer portion of the braided, woven or embroideredloop23,27 prior to its attachment toouter catheter element12. The inner catheter control element orfilament19 may make one, less than one or more than one loop inside of theexpansile loop24,25 prior to exiting and attaching tocatheter element12. In this manner the innercatheter control element19 forms a “snare” or loop of one or multiple turns. If the innercatheter control element19 is of sufficient stiffness, for example but not limited to, a metallic guidewire of 0.010″-0.040″ diameter, the snare may be opened by advancing the proximal portion of the innercatheter control element21 while holding theouter catheter element12 and proximal end of theexpansile loop23,27 in place. This opening of the circumference of one or more loops of the snare formed by the innercatheter control element19 will result in an expansion of the circumference of theexpansile loop24,25 as the inner portion of theexpansile loop24,25 pulls out of its outer portion. Once the limits of expansion of theexpansile loop24,25 have been reached, the innercatheter control element19 may be pulled back into thecatheter element12 by pulling on itsproximal portion21. This causes one or more loops of the snare becoming smaller pulling on the inner circumference of the expandedexpansile loop25 resulting in a contraction of the central space in the middle of the expandedexpansile loop25. Due to the braided, woven or embroidered nature of theexpansile loop24,25, theexpansile loop24,25, will remain generally in the shape of a toroid both upon its circumferential expansion and its central contraction.
• In an alternative embodiment of the present invention for annular repair or replacement, the innercatheter control element19 is run inside of theexpansile loop24,25 which is looped and exits first the distal end of the inner section of the braided, woven or embroideredloop22,26 and then exits through the wall of the outer portion of the braided, woven or embroideredloop23,27. Prior to exiting through the wall of the outer portion of the braided, woven or embroidered loop, the innercatheter control element19 may pass through a slip-lock attached to the more proximal portion of the control element, thereby forming a snare loop with itself. This slip lock may allow the control element to lock in place as the snare is contracted in circumference, similar to a “tie wrap” or cable wrap, commonly used to hold cables together. This snare may be opened by advancing the proximal portion of the innercatheter control element21 while holding the slip lock portion in place. This opening of the circumference of one or more loops of the snare formed by the innercatheter control element19 will result in an expansion of the circumference of theexpansile loop24,25 as the inner portion of theexpansile loop24,25 pulls out of its outer portion. Once the limits of expansion of theexpansile loop24,25 have been reached, the innercatheter control element19 may be pulled back into thecatheter element12 by pulling itsproximal portion21 through the slip lock. This causes one or more loops of the snare becoming smaller pulling on the inner circumference of the expandedexpansile loop25 resulting in a contraction of the central space in the middle of the expandedexpansile loop25. Due to the braided, woven or embroidered nature of theexpansile loop24,25, theexpansile loop24,25, will remain generally in the shape of a toroid both upon its circumferential expansion and its central contraction.
• As shown inFIGS. 10-13, anotherembodiment43,44 of the present invention comprises anelongated probe15, with aproximal end17 and adistal end16. Referring toFIGS. 10 and 11, a first innercatheter control element19 is slideably located within theouter catheter element12. At theproximal end17 ofelongated probe15, the innercatheter control element19 exits from theouter catheter element12, and can be advanced or retracted causing thedistal end20 of the innercatheter control element19 to move in or out of thedistal end13 of theouter catheter element12. The first innercatheter control element19, in the form of a filament, guidewire or flexible tube, slideably extends from theproximal end17 of theprobe15, through the lumen of theouter catheter element12, and exiting theouter catheter element12 at itsdistal end13. The innercatheter control element19 then enters the inside of the outer section of theexpansile loop24 at itsproximal end23. The innercatheter control element19 may be looped one, less than one, or more than one time within theexpansile loop24 between the inner and outer portions of theexpansile loop24 prior to the inner catheter element orcontrol element19 terminating within theexpansile loop24. The innercatheter control element19 is then attached to theexpansile loop24 at itsdistal end22. This embodiment also includes a second innercatheter control element52 which extends from theproximal end17 of the catheter orprobe15, through theouter catheter element12, and exiting theouter catheter element12 at itsdistal end13. The second innercatheter control element52 then enters the outside of the outer section of theexpansile loop24 and is attached to thedistal end22 of theexpansile loop24. A coveringretractable sheath18 is placed over theelongated probe15 to hold it in a constrained condition for delivery into the vertebral disc. After thesheath18 is retracted, the second interiorcatheter control element52 is pulled back into the outercatheter control element12 by pulling on its proximal end. This causes the distal end of theexpansile loop22 to be pulled from inside the outer portion of theexpansile loop24 expanding the outer circumference of the expansile loop24 (SeeFIG. 12). Now referring toFIG. 13, the first innercatheter control element19 may be pulled back into theouter catheter element12 by pulling on its proximal end. This will result in a pulling in of the center of theexpansile loop25 towards the middle of the loop and contraction of central space in the middle of theexpansile loop25. Due to the braided, woven or embroidered nature of the tubularexpansile loop24,25, theexpansile loop24,25, will remain generally in the shape of a toroid both upon its circumferential expansion and its central contraction.
• In anotherembodiment59,60 as represented inFIGS. 18-20, the contracted configuration of theexpansile loop58 comprises anexpansile loop58 which has a portion folding back into itself or invaginated56 (seeFIG. 20). This forms a complete toroid with a portion invaginated to form a diametrically contracted toroid with an inner section and an outer section that are continuous with each other. Pulling on the innercatheter control element19 in the manner previously described will function to increase the diameter (+D) and increase the height (+H) of the expandedexpansile loop25 as the central portion of the toroid is pulled towards the center.
• The entireexpansile loop assembly10 including the circumferentially contracted braided, woven or embroideredexpansile loop24, and innercatheter control element19, may now be compressed into the distal outer catheter element, asheath18 or alternatively into anaccess tube38 of approximately 3-20 mm diameter for ease of placement. Theaccess tube38 may be formed from any suitable material, as the present invention is not limited in this respect. Thus, theaccess tube38 may be formed from a plastic material, such as a polycarbonate, or a metal material, such as stainless steel, or any suitable combination of materials. In addition, the postero-lateral access tube38 may be formed of a material that can be readily sterilized. Further, theelongated probe15 may be formed as a single use device such that resterilization is not required after use. Theposterlateral access tube38 gains access to the vertebrae generally using a posterior approach (FIG. 14).
• As shown inFIG. 15, theposterlateral access tube38 has gained access to thevertebrae32, having aspinal cord33, anannulus36 and anucleus area34. Once in proper position in thevertebrae32 of a patient, theexpansile loop24 may be ejected into thenucleus area33 or the annulus area (not shown in this Figure) from the distal end of theouter catheter element13,sheath18 oraccess tube38 by retracting theouter catheter element12 orsheath18 and simultaneously holding theinner catheter19 andexpansile loop24 in a fixed position. Alternatively, an additional “pusher” element (not shown) can be advanced distally into theouter catheter element12 orsheath18 or access tube and eject theexpansile loop24,catheter element12 and the distal innercatheter control element20 from the end of thesheath18. As previously described in the embodiments above, theexpansile loop24 may now be circumferentially expanded by either pulling on or pushing the innercatheter control element19 in the manner described above. Furthermore, if it is desired that the central portion of the braided, woven or embroideredexpansile loop24 become circumferentially contracted, pulling on the innercatheter control element19 as described above will accomplish this feature.
• Now referring theFIG. 16, the expandedexpansile loop25 achieves the desired outer circumferentially expanded and inner circumferentially contractedsize48, when the innercatheter control element19 is locked or tied in place with a knot. This can also be accomplished by a locking junction located at theouter catheter element12. Thedistal portions20 of the external innercatheter control element19 can now be disconnected or cut from a connector or proximal to the knot. The connector or knot is also separated from the distalouter catheter element12. This then leaves an outer circumferentially expanded and inner circumferentially contractedexpansile loop25 in place as a closed loop in the desired location (shown inFIG. 16 expanded with the nucleus area34) within the inter-vertebral space.
• As represented inFIG. 21 an additional feature of the present invention with an innercatheter control element41 having a plurality ofdistal holes42 for delivery and injection of biomaterials which can be utilized with the embodiments of the present invention. The innercatheter control element41 withholes42 comprises a tubular structure with a central lumen from theproximal end17 of theouter catheter element12 communicating with side holes in thedistal end13. The proximal end of the inner catheter or control element may be fitted with an injection device (e.g. syringe). The innercatheter control element41 is contained within the continuous interior chamber of the expandedexpansile loop58. Theholes42 in the innercatheter control element41 are designed to be only within the continuous inner chamber. Furthermore, it is anticipated that the holes can be of different size along the length of the inner catheter control element to equalize biocompatible material delivery (e.g. larger holes at the distal end, smaller holes at the proximal end). In addition, it is anticipated that the holes can be in various configurations, e.g. oval, or can be a plurality of slots or other similar opening.
• FIG. 22 is another feature of the present invention that can be used with several of theembodiments11,44,60,62 wherebynon-permanent locking elements30 on the distal end of the expansile interior loop are engaged to thedistal end26 of the expansile outer loop. The locking elements are extended portions of one end of the braid or loop which interlock with the braid or loop pattern. The locking elements function to maintain a desired diameter of the expansile loop after expansion.
• In one method of clinical use, the nucleus of the damaged disc has been previously removed by discectomy techniques either through an anterior, posterior or posterolateral surgical approach. The expansile loop annular repair orreplacement device10 in its compressed configuration within theouter catheter element12 orsheath18 is advanced through an access tube or cannula previously placed into the inter-vertebral space. This cannula may access the inter-vertebral space from a posterior, posterolateral or anterior approach that is well known to physicians skilled in the art. Thepresent invention10 is then advanced into the inter-vertebral space through theaccess tube38. Once the distalexpansile loop24 is advanced through theaccess tube38 into the vertebral space it is diametrically expanded by either retraction or advancement of the innercatheter control element19 in the manner previously described. The distalexpansile loop25 expands to the limits of the inner portion of the remains of the native annulus and remains diametrically expanded and transversely contracted as illustrated inFIG. 6. Any of a number of previously described artificial nuclei puposi may then be placed in the center of the diametrically expandedexpansile loop48 either via direct visualization from the traditional surgical approach or via endoscope from a posterolateral approach through the foramina or form a posterior approach. These artificial nuclei may then be allowed to expand either through the absorption of liquids, as is the case for hydrogel based devices, or through the injection of material into the nuclear prosthesis.
• Once the nuclear replacement is in place, any remaining space between the nuclear replacement and the expansile loop annular replacement device may be reduced or eliminated by centrally contracting the inner circumference of the toroid formed by the expansile loop device. This is accomplished in the manner previously described by pulling back the inner catheter control element resulting in contraction of the inner circumference of the device until it abuts the nuclear replacement. The braided, woven or embroidered design of theexpansile loop48 will also allow it to flex and bend to conform to the inter-vertebral space. By properly selecting the material from which the expansile braided, woven or embroidered loop is constructed and by properly selecting the design of braid for its manufacture as previously described, the expansile braided, woven or embroidered loop will now function as a complete circumferential support for the artificial nucleus. The expansile braided, woven or embroidered loop will prevent extrusion of the artificial nucleus through any defects in the remaining native annulus and act to stabilize the artificial nucleus during both bending and motion of the spine and throughout the healing process. The braided, woven or embroidered design of the expansile loop will also permit it to flexibly bend as the central nucleus replacement expands and swells to its final size. The braided, woven or embroidered design of the expansile loop will also permit tissue in growth to occur as healing occurs. This will result in stabilization of the artificial nucleus.
• In an alternative method, once the expansile braided, woven or embroideredloop48 has been expanded to fill the inter-vertebral space between the artificial nucleus and the native vertebrae and remaining native annulus fibrosis, theexpansile loop48 may be filled with a suitable biologically compatible material. Such suitable materials that can be directly injected through the innercatheter control element19 if it includes a central lumen and openings connecting with the interior chamber of the expansile braided, woven or embroidered loop as illustrated inFIG. 11. Alternatively, the biocompatible materials can be injected using a separate catheter element which can be advanced along the inner catheter control element into the interior chamber of the expansile braided, woven or embroidered loop. Alternatively, the biocompatible materials could be injected into the interior chamber of the expansile braided, woven or embroidered loop using a separate catheter or injection needle which pierces the side of the braided, woven or embroidered loop once it is expanded and in place in the inter-vertebral space. Biocompatible materials which may be injected include biocompatible viscoelastic materials such as hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof. The viscosity of the injected fluids must allow them to be injected either via catheter or needle into the braided, woven or embroidered expansile loop. The injected biocompatible material must cure or polymerize in situ within the expansile braided, woven or embroidered loop and within the disc space. Such in situ curing of the biocompatible material may be the result of mixing of multiple components and polymerization, temperature change in going from room to body temperature or elevated to body temperature, or other forms of energy such as light or electricity applied to the injected material.
• In addition, suitable materials that can be placed directed into theexpansile loop48 and allowed to expand through the absorption of liquids such as water include, but are not limited to, swelling hydrogel materials (e.g. polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels). Examples of suitable materials for solid or semi-solid members include solid fibrous collagen or other suitable hard hydrophilic biocompatible material. The swelling of these materials may result in further expansion of the expansile braided, woven or embroidered loop and an increase in the inter-vertebral disc height.
• In some cases, a multiphase system may be employed, for example, a combination of solids, fluids or gels may be used. Such materials may create primary and secondary levels of flexibility within the braided, woven embroidered expansile loop and within the vertebral disc space.
• For example, the hydrogel materials (e.g. polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels or combinations can be dissolved in a solvent, such as dimethylsulfoxide, analogues/homologues of dimethylsulfoxide, ethanol, ethyl lactate, acetone, glycerin or combinations thereof. Small amounts of water could also be added to the solvent/hydrogel combination to adjust the solutions viscosity. This solvent/hydrogel combination can be injected into the inter-vertebral space to replace the nucleus, the annulus, or both the nucleus and annulus. Theexpansile loop48 will assist in containing and supporting the solvent/hydrogel combination. After delivery, the solvent is replaced by bodily fluids and the hydrogel precipitates out of solution into a hydrated solid. The solvent is adsorbed into the body tissues. Introducing an aqueous solvent, such as water or saline, into the inter-vertebral space containing the solvent/hydrogel combination can be performed to increase the precipitation speed of the hydrogel. This second step facilitates the precipitation or solidification of the hydrogel material which swells and fills the desired inter-vertebral space.
• Once theexpansile loop48 is filled with a suitable material and the material has cured or partially polymerized, the inner catheter control element orfilament19 can be withdrawn by removing its distal connection to the junction point with theouter catheter element12 or at its termination within the braided, woven or embroidered expansile loop and pulling the inner catheter control element out of the expansile loop. Alternatively, the innercatheter control element19 may be cut off or disconnected at its entry point into the expansile loop. This leaves a complete toroid without defect, formed of the expansile loop in place to act as an annular reinforcement or replacement which may or may not surround an artificial nucleus device.
• In another method of clinical use, after the braided, woven or embroideredexpansile loop48 has been expanded to its maximum diametric dimension, acting as a reinforcement or replacement for the damaged native annulus, the device may be centrally circumferentially contracted, as previously described, to fill any remaining space previously occupied by the native nucleus prior to nuclectomy. The braided, woven or embroideredexpansile loop48 expands to the limits of the remains of disc space and the remains of the native nucleus and annulus and remains diametrically expanded and centrally circumferentially contracted. Now the braided, woven or embroidered expansile loop area may be filled with a biomaterial or any suitable material (as described above), as the present invention is not limited in this respect. In addition to the materials disclosed for annulus replacement, additional suitable fluid materials for nucleus and annular replacement include, but are not limited to, various pharmaceuticals (steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics); growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils); and saline.
• Once the expansile loop is filled with a suitable material in the central and circumferentially contracted nuclear area and the annular area, the innercatheter control element19 can be withdrawn by removing its distal connection to the junction point with theouter catheter element12 and pulling the inner catheter control element out of the expansile loop. Alternatively the inner catheter control element orfilament19 may be disconnected from its attachment to the distal inner braided, woven or embroidered expansile loop prior to its removal. Alternatively, the inner catheter control element orfilament19 may be cut off at its entry point into the outer section of expansile loop using a surgical tool. This leaves a complete toroid, without defect, formed of the expansile loop in place to act as an annular and nucleus reinforcement or replacement.
• In another method of clinical use, the present invention can be advanced into the vertebral space once a nuclectomy has been performed. Once the braided, woven or embroideredexpansile loop24 is advanced into the vertebral space, it is diametrically expanded in the manner previously described. The braided, woven or embroideredexpansile loop25 expands to the limits of the out portion of the remains of the native nucleus and remains diametrically expanded and transversely contracted. Now the braided, woven or embroideredexpansile loop48 may be filled with a biomaterial of any suitable material, such as those previously noted, as the present invention is not limited in this respect. This injected material is allowed to cure or polymerize to some extent, and then the central portion of the expansile loop is circumferentially contracted in the manner previously described. At this point the central nuclear area of the vertebral space is filled with the expanded mesh. This central portion can then be filled with biomaterial or any suitable material, such as those previously noted, as the present invention is not limited in this respect. In addition to the materials disclosed for annulus repair or replacement, additional suitable fluid materials for nucleus replacement include, but are not limited to, various pharmaceuticals (steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics); growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils); and saline.
• Once the braided, woven or embroidered expansile loop is filled with a suitable material in the nucleus area, the innercatheter control element19 can be withdrawn by removing its distal connection to the junction point with theouter catheter element12 or its distal connection with the distal inner expansile loop, and pulling the innercatheter control element19 out of the expansile loop. Alternatively, the inner catheter control element orfilament19 may be cut off at its entry point into the expansile loop using a surgical tool. This leaves a complete toroid, without defect, formed of the expansile loop in place to act as an annular reinforcement or replacement and/or nucleus reinforcement or replacement. It also allows the annular area of the device on the periphery and the nucleus portion of the device in the central region to have different physical properties dependent on the differential biocompatible materials injected into each region.
• In an additional method of clinical use, once the nucleus of the disc has been removed, thepresent invention10 is advanced into the inter-vertebral space. The braided, woven or embroideredexpansile loop24 is diametrically expanded in the manner previously described. The distal interior braided, woven or embroideredexpansile loop25 is pulled out of the outer expansile loop and the overall expansile loop diametrically expands to the limits of the inner portion of the native annulus. Next the innercatheter control element19 is pulled back out of the expanded expansile loop and the inner potion of the inner catheter orfilament loop19 pulls in the inner circumference of the expansile loop, making the central hole smaller and the braided, woven or embroideredexpansile loop48 transversely wider to better fill the central defect in the vertebral space. This expanded braided, woven or embroideredexpansile loop48 may be used to contact a central prosthetic nucleus previously placed in the middle of the braided, woven or embroidered expansile loop. In the case where no additional nucleus prosthesis is desired, the central portion of the braided, woven or embroidered expansile loop can be been expanded to the point where essentially nocentral hole37 remains in the toroid. The fully expanded braided, woven or embroidered expansile loop can now be injected with a suitable biocompatible material (as described above) which will expand or cure in situ as previously described. In this case the present invention will function as both a prosthetic annulus and a prosthetic nucleus and its load bearing properties will be dependent on the properties of the polymer chosen to fill the expansile loop.
• Additionally, a hydrogel, polymer or biocompatible material may be injected into the interior chamber of the expansile loop such that the biocompatible material has the capacity to swell or increase in size as the result of absorbing water or liquid. This would result in further expansion of the expansile braided, woven or embroidered loop and an increase in the inter-vertebral disc height.
• In another method of clinical use, the intended treatment is to fuse two adjacent vertebrae using thepresent invention10. Again using the illustration inFIGS. 10, the end of the innercatheter control element19 is attached to the interior anddistal end22 of the braided, woven or embroideredexpansile loop24. To expand the diameter of the expansile loop one merely needs to stabilize the proximal portion orouter end23 of the braided, woven or embroidered expansile loop and pull back the inner catheter control element orfilament19 or wire. This will result in the inner section of the braided, woven or embroidered expansile loop pulling out of the outer section of the braided, woven or embroidered expansile spiral as the wire is retracted. Once the desired outer diameter of the braided, woven or embroideredexpansile loop48 is achieved, the central portion of the braided, woven or embroideredexpansile loop48 may be contacted by pulling the same innercatheter control element19 further back out of the proximal portion of the braided, woven or embroidered expansile loop. The inner loop portion of the inner catheter control element orfilament19 will contract in diameter and pull on the inner circumference of the braided, woven or embroideredexpansile loop48 resulting in the central “hole” of the toroid becoming smaller and smaller indiameter37. This results in the transverse diameter of the toroid becoming bigger while the outer diameter stays the same. Once the desired size is reached, the wire may be held in place and a polymeric or other biologically compatible material as describe above injected into the toroid either through the inner catheter control element, which may be in the form of a hollow catheter or hypotube, or alternatively via a catheter which is advanced into the toroid along the inner catheter control element orfilament19 or separately using a catheter or needle for injection. The fully expandedexpansile loop48 can now be injected or filled with a suitable material for fusing the two adjacent vertebrae together. Candidates for a suitable fusing material include, but are not limited to, bond graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.
• Once the bone fusing material has been injected the innercatheter control element19 may be removed by retracting it from the braided, woven or embroidered expansile loop. Alternatively, the innercatheter control element19 may be cut off at its entrance point into the toroid. In another embodiment (not illustrated) the expansile loop may be expanded in diameter using an inner filament of sufficient stiffness such as the metal wire described and the central hole may be made smaller by pulling on a separate flexible filament such as a thread attached to the inner radius of the braided, woven or embroidered expansile loop.
• In this embodiment of fusing two adjacent vertebrae together, it may be desirable to stimulate growth of bone through the fill material. To facilitate bone integration and growth, the expansile loop should have openings that are more porous. The pores or openings of the expansile loop will have a diameter of about 0.25 mm to about 5.0 mm. The size is selected to allow tissue in-growth while containing the material packed into the expansile loop. It is also contemplated that the expansile loop can be seeded in vitro with bone forming cells, such as osteoblasts, and/or with growth factors. Multiple layers of osteoblast-seeded applications may be stacked on top of one another and further allowed to or encouraged to proliferate. In addition to in vitro seeding of osteoblasts, other treatments for the braided, woven or embroidered expansile loop are contemplated that also provide an implant that allows for bone in-growth and regeneration of bony tissue. For example, the expansile loop can be coated with a demineralized bone matrix or smeared or coated with an osteoinductive bone paste, such as OSTEOFIL™. In addition, the expansile loop can be coated with collagen, and subsequently soaked in a pharmacological agent such as recombinant human bone morphogenic protein, antibiotic agents, or other similar material.
• Additional materials for the embodiments of the present invention to be delivered into the expansile loop and/or the center hole (toroid) include certain biocompatible cement and plaster of Paris materials. Cement products employ a binding agent to hold silicone materials or sand and other aggregates together in a hard, stone like mass. Other chemicals can be added to the cement components to affect the curing time and final plasticity of the cement product. Plaster of Paris biomaterials are formed from calcium sulfate and are ideal materials for molding, casting and making various forms. The hardness of the plaster of Paris biomaterials can attain a relatively high hardness (Shore A Hardness of65 +/−5) and can fully harden in 30 minutes of less. Both the biocompatible cement and plaster of Paris materials are desirable candidate materials to be used deliver and fill within the expansile loop or center hole of the present invention for the fusing two adjacent vertebrae together.
• Example of calcium phosphate-based bone substitutes having the necessary characteristics consist of calcium phosphate being a substantially monolithic tetracalcium phosphate (CA₄(PO₄)₂O). The calcium phosphate may further comprise surface protrusions of calcium phosphate to enhance bone integration. Alternatively, the suitable calcium phosphate-based bone substitute can comprise minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HP₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and the like. The suitable bone substitute can also comprise an amount of one or more active agents suitable to promote bone growth, such as a growth factor, a bone morphology protein, or a pharmaceutical carrier therefor.
• An additional feature that can be incorporated to all of the embodiments disclosed herein is the means for attaching or securing the expansile loop ormesh59,60,61,62 to the surrounding disc structures, theannulus36 and/or the native orartificial nucleus34 or the vertebral endplates35. One benefit of the described invention is that the attachment means64 can secure the circumferential expansile loop ormesh59,60,61,62 to healthy tissue located away from a damaged area or on the opposite side of the hernia or clinical entry site.
• Shown inFIG. 23 is a cross sectional view of the attachment means64 in the from of asuture66 and demonstrating asuture delivery system68 already advanced through anaccess tube38 and utilizing non-absorbable orre-absorbable sutures66 to attach the contracted configuration of theexpansile mesh59,61 to the inner wall of theannulus36 at multiple points. Although not shown inFIG. 23, it is anticipated by the Applicants that thesuture delivery system68 can be used without theaccess tube38 and can be advanced with or with the aid of endoscope through the access opening or potentially a hernia opening to perform the attachment procedure. Furthermore, other traditional surgical or manipulation techniques not utilizing adelivery system68 can be used with or without the aid of an endoscope through the access opening or potentially a hernia opening to perform the attachment procedure.
• The attachment means64 for securing the expansile loop or mesh to theannulus36 or native/artificial nucleus34 could be through the use of previously known technology such as sutures, clips, tacks, anchors, staples, screws, buttons, T-shaped tags, barbed tags, adhesives or other similar devices having appropriate securing characteristics. The term “attachment means” used herein encompasses sutures, clips, tacks, anchors, staples, screws, clamps, buttons, T-shaped tags, barbed tags and other tissue holding means and delivery/manipulation techniques.
• Whereby sutures66 are known to be the standard in holding strength, the use of tacks, staples and other fasteners continue to be developed and implemented. Since the delivering, manipulating and retrieving a suture, often in a very tight surgical site is difficult the use and delivery of non-suture attachment means through a small opening to hold torn tissue have been shown to have a clinical advantage.
• FIG. 24 shows a cross sectional view of the attachment means64 in the form of a staple orhelicoil70,71 with adelivery system72 already advanced through theaccess tube38 and utilizing non-absorbable or re-absorbable stables orhelicoil mechanism70 to secure the expandedexpansile mesh60,62 to the inner wall of theannulus36 at multiple points. The staple or helicoil is being provided as an example in this Figure since the attachment means64 could be clips, tacks, anchors, staples, screws, clamps, buttons, T-shaped tags, barbed tags and other tissue holding means and delivery/manipulation techniques. Also shown inFIG. 24 is a cross sectional view of the a staple orhelicoil delivery system72 already advanced through theaccess tube38 and utilizing non-absorbable or re-absorbable stables or helicoils71 to attach the expandedexpansile mesh60,62 to the outer wall of the native orartificial nucleus34 at multiple points. Although not shown inFIG. 24, it is anticipated by the Applicants that thehelicoil delivery system72 can be used without theaccess tube38 and can be advanced with or with the aid of an endoscope through the access opening or potentially a hernia opening to perform the attachment procedure. Furthermore, other traditional surgical or manipulation techniques not utilizing adelivery system72 can be used with or without the aid of an endoscope through the access opening or potentially a hernia opening to perform the attachment procedure.
• The attachment means64 is designed to engage the outer surface of the expansile mesh and then engage the either theannulus36 or thenucleus34, securing the expansile loop or mesh in place. Besides securing the expansile mesh or loop in place, the use of an attachment means to secure the expansile mesh or loop can facilitate the in-growth of new tissues.
• The annulus/nucleus attachment means64 could be installed within the expansile mesh prior to insertion with the vertebral space. Alternately the annulus/nucleus attachment means64 can be installed within the expansile mesh after is inserted into the disc in a contacting configuration or after the mesh is expanded in the disc. The annulus/nucleus attachment means64 could be made from materials that are biodegradable or bioabsorbable such as resorbable collagen, LPLA (poly(l-lactide)), DLPLA (poly(dl-lactide)), LPLA-DLPLA, PGA (polyglycolide), PGA-LPLA or PGA-DLPLA, polylactic acid and polyglycolic acid which is broken down and bioabsorbed by the patient over a period of time.
• Furthermore, as shown inFIG. 25, the expansile loop ormesh60,62 could be expanded and secured to an endplate35aor35bor both endplates35aand35bof the vertebral body. Also shown isannular tissue36 sandwiched between the two vertebral endplates35. Such attachments means64 are the same as theannulus36 means but are designed for placement into hard bony tissues. This includes bone screws, anchors, andother means74 for attachment to hard tissue.
• Attachment to the native nucleus could be required if a partial nuclectomy is performed. Attachment to anartificial nucleus34 could be performed following nuclectomy and placement of an artificial nucleus. Attachment ofexpansile mesh60,62 to theartificial nucleus34 could stabilize the artificial nucleus and/or maintain the artificial nucleus's position during delivery, during mesh expansion and over time.
• Attachment of theexpansile mesh60,62 to theannulus36, native orartificial nucleus34, or the endplates35 could encourage in-growth of body tissues throughout theexpansile mesh60,62 and therefore function to reinforce and repair the annulus and strengthen the annulus or nucleus. Overall, the placement of the attachment means64 into healthy tissue will increase long-term stability.
• One significant advantage of the described invention and attachment means is that the attachment means may be placed into healthy annular tissue located distal to the annulectomy site or site of hernia defect. This is due to the complete circumferential nature of the expansile loop within the inner surface of the annulus. This is an advantage over previously described systems used to patch a hole created in the annulus in the area of a hernia defect or diseased tissue.
• In addition, theexpansile mesh59,60,61,62, can include materials that will act as a scaffold or carrier for delivering biologic medicaments to vertebral tissues. The expansile mesh can be previously treated (for example, by soaking) with certain biologics (e.g. BMP, OP-1), or the access tube can be constructed to include a biologic delivery means such that the biologic is 1) delivered while the attachment means64 is being deployed, 2) delivered prior to deploying the attachment means64,3) delivery subsequent to deploying the attachment means64, or any combinations thereof.
• For example, the present inventionexpansile mesh59,60,61 and62 can be coated or integrated with an osteogenic paste composition including a paste-form carrier such as a gelatin paste and at least one osteogenic factor such as BMP-2 or another similar bone morphogenetic protein. The inclusion of osteoblast- and osteoclast-stimulating osteogenic factors in a paste-form composition including a resorbable paste carrier causes a rapid and premature resorption of the carrier. This rapid resorption of the carrier can diminish or eliminate the capacity of the paste-form composition to effectively stimulate and support new bone formation in a void filled with the composition. This is particularly the case in humans in which the rate of new bone formation is relatively slow.
• In another method of clinical use, the several embodiments of the present invention can be advanced into the vertebral space once a nuclectomy has been performed, as shown inFIG. 26. Once the braided, woven or embroideredexpansile loop24 is advanced into the vertebral space (FIG. 27), it is diametrically expanded in the manner previously described and as shown inFIG. 28. The braided, woven or embroideredexpansile mesh25 is expanded to the limits of the inner portion of the native annulus and becomes diametrically expanded and transversely contracted. In this clinical use, an innercentral area80 surrounded by the inner surface of the expansile mesh is formed as the expansile mesh is expanded and contracted. For the purpose of demonstration, a delivery probe82 is inserted between some of the mesh layers of the expansile loop in an anterior approach (FIG. 28). It is anticipated and preferred that thedelivery probe80 be inserted through theouter sheath18 in a posterior or posterolateral approach (not shown).
• FIG. 29 shows that the delivery probe82 has been inserted through both the outside and inside mesh layers, with its terminal end projecting into the innercentral area80. Now the innercentral area80 may be filled with any suitable biomaterial, such as those previously noted, as the present invention is not limited in this respect. This injected material is allowed to cure or polymerize to some extent, and then the central portion of the expansile loop is circumferentially contracted in the manner previously described. Alternatively, the centraltoroidal area80 can be filled a suitable materials to induce bone fusion including, but are not limited to, bond graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone chips, bone graft materials, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof, or a biomaterial or any suitable material (as described above), as the present invention is not limited in this respect.
• A feature or characteristic of the present invention expansile mesh that has been exemplified inFIGS. 16, 17,23,24, and26-29, is that the braided, woven or embroidered design and the flexibility of the expansile loop or mesh allows the insertion of delivery probes and other similar devices without the need for a dedicated hole. As shown inFIG. 30, the expansile mesh generally has a non-disturbed cross-pattern. Since the layers of this cross-pattern braided, woven or embroidered expansile mesh are fabricated from a flexible material, when a delivery probe or similar device is inserted, the weave flexes and creates an opening between the individual layers, allowing for simple and effortless penetration (seeFIG. 31). When the delivery probe or similar device is retracted from the expansile mesh, the individual layers return to their original undisturbed cross-pattern configuration, as shown inFIG. 30.
• This design characteristic has several advantages. First, since there is no dedicated hole, penetration or insertion of a delivery probe can be accomplished generally through any section of the expansile mesh with relative ease. Hence, the clinician has the opportunity to attempt the insertion of a delivery probe from various approaches, e.g. antegrade, posterior, and at various angles, thereby significantly increasing the potential insertion sites and increasing the overall success of the procedure. Second, since the mesh returns to its original undisturbed cross-pattern configuration after the probe or similar device has been retracted, there is no hole or void that must be closed or sealed to prevent leakage of delivered biomaterials.
• In an alternative embodiment of the current invention, the braided, woven or embroidered expansile loop may be looped around a bone graft such as a bone allograft, autograft, bone cage or the like, and advanced into the vertebral space. As can be seen inFIG. 32 which shows a top view cross-section of a spinal body (vertebrae)32 wherein one of the embodiments of the present invention's includes a boneblock delivery apparatus95 having ashaft90 that is coaxially engaged with a firsttubular member92 and a secondtubular member93, further wherein theshaft member90 has a terminal end with an attachment means96 temporarily engaged with abone block100 that is enclosed within the present inventionexpansile loop10,39,43,59,61 in a contracted configuration. Next as shown inFIG. 33, one of the embodiments of the present invention's is used with the boneblock delivery apparatus95 having ashaft90 that is coxially engaged with a firsttubular member92 and a secondtubular member93, further wherein theshaft member90 is temporally engaged to abone block100 that is enclosed within the present inventionexpansile loop10,39,43,59,61 in a contracted configuration and being positioned within theinter-vertebral space51. Then the expansile braided, woven or embroidered loop is then diametrically expanded in the manner previously described and as shown in more detail inFIG. 34. The braided, woven or embroideredexpansile loop11,40,44,59,62 is expanded to the limits of the inner portion of the native annulus and becomes diametrically expanded and transversely contracted by pulling thecontrol elements12. In the innercentral area80 surrounded by the inner surface of the expansile mesh now contains the bone graft material. The expansile mesh is now substantially centrally contracted around the bone graft in order to stabilize the bone graft and prevent displacement of the bone graft.
• InFIG. 35 it is shown that theshaft member90 has a terminal end with its attachment means96 disengaged from abone block100 that is enclosed within the present invention expansile loop in a expanded configuration while positioned within the inter-vertebral space. As can be seen from the example in this Figure, the attachment means94 can be a treaded means with male thread94 on the terminal end of theshaft90 designed to engage afemale thread97 in thebone block100.
• InFIG. 36 which is top view cross-section of a spinal body (vertebrae)32 wherein theshaft90 is retracted, wherein the shaft90 (shown retracted) or other instrument (not shown) urges thebone block100 to move from a vertical position102ato a horizontal position102balong the anterior wall of the annulus.
• FIG. 37 demonstrates a top view cross-section of a spinal body (vertebrae)32 with one of the embodiments of the present invention's11,40,44,59,62 delivers a plurality ofmaterials104 to the innercentral area80 located in close proximity to the originalvertebrae nucleus area53. Using either the firsttubular member92 of the boneblock delivery apparatus95 or another delivery probe82 that can be inserted between both or one layer of the expandedexpansile loop11,40,44,59,62 in an anterior approach, posterior or posterolateral approach.Suitable materials104 to induce bone fusion including, but not limited to, bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, allograft, autograft bone chips, bone graft materials, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof, or a biomaterial or any suitable material (as described above), may now be inserted through the boneblock delivery apparatus95 of the delivery probe82 and placed either into thecentral area80 surrounding thecentral bone block100 or cage or into the inner lumen of the toroid created by the previously expandedexpansile mesh11,40,44,59,62. The expansile loop may now contract centrally using the control elements in the manner previously described. This results in compression of the bonegraft materials and bone block together. This would result in increased stability of the bone graft materials, increased pressure against the endplates to augment fusion and increased resistance to displacement or pullout of the bone block and chips.
• Now referring toFIG. 38, disclosed is anotherembodiment111 of the present invention using one version of a lockingstrap control element112. The lockingstrap control element112 resembles the standard cable ties used in the electronic industry e.g. for holding cables together. However, the lockingstrap control element112 has various differences a will be described below.FIG. 38 shows a top cross-section view of a spinal body (vertebrae)32 with one of the embodiments of thepresent invention111 having the locking straptype control element112 expanded within the vertebral space. The locking strap control element encircles with the central cavity of theexpansile loop24,25.
• One of the important features of the locking strap control element is that it has adequate rigidity which enables the physical expansion and/or contraction of the expansile loop or mesh within the inter-vertebral space. For example, by contracting and expanding the expansile loop or mesh the diameter of the inner central (toroidal)area116 is reduced or expanded, respectively. In addition, further expansion of the locking strap control element will diametrically expand the expandable mesh allowing the outer wall of the mesh to engage the conformation of the annular wall, providing support for the native and/or diseased sections, and treated or repaired areas of the annulus.
• FIG. 39 is a side cross-section view of a spinal body (vertebrae)32 with one of theembodiments111 of the present invention having a locking straptype control element112 and showing a resulting configuration of a side view of theexpansile loop114 which includes the inner wall of the toroidal expansile loop surrounding the inner central (hole) area and curved towards that area in a concavo-concave configuration. The outer or annular wall of the toroidal expansile loop curves in towards the annular surface and away from the central area in a convex manner.
• FIG. 40 is a perspective view of one type of lockingstrap control element112 of the present invention comprised of head with an integrated locking mechanism attached to an elongated strap. The lockingstrap control element112 includes various differences from cable ties uses in the electrical industry. For example, the head of the locking strap control element is specifically configured to have a low profile and minimization of any protruding edges. Also, the head is designed with various configurations to enable the engagement with various tools used in the spinal industry, e.g. a bone holder or an adjustment tool.
• Suitable non-degradable materials for the lockingstrap control element112 include, but are not limited to, Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluroethylene (e-PTFE), polyetheretherketone (PEEK), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) commercially available as Spectral or Dyneema™, as well as other high tensile strength materials such as Vectran™, Kevlar™, natural or artificially produced silk and commercially available suture materials used in a variety of surgical procedures.
• FIG. 41 is a magnified perspective view of one type of lockingstrap control element112 of the present invention comprised of lockinghead120 attached to anelongated strap118. The lockinghead120 includes aratchet tab119 designed to engaged thelocking gear rack124 of theelongated strap118.
• FIG. 42 shows the elongated strap inserted within the lumen of the lockinghead120 forming acircular loop121 whereby advancing or retracting thestrap118 within the lockinghead120 either increases or decreases the diameter of the loop. Thefinal loop121 diameter is then maintained by the ratchet tab engaged to one or two of the teeth of thelocking gear rack124.
• FIG. 43 is a cross-section taken fromFIG. 41 whereby the section plane extends through the ratchet tab orpall119.
• FIG. 44 is a cross-section fromFIG. 41 whereby the section plane extends along one side of the ratchet tab orpall119.
• FIG. 45 is a perspective view of a second type of lockingstrap control element128 of the present invention comprised of an elongated strap with a non-locking head and designed to cooperate with a locking mechanism.
• FIG. 46 is a magnified perspective top view of a second type of lockingstrap control element128 of the present invention comprised of a non-locking head attached to an elongated strap. Thehead132 is specifically configured to have a low profile and includes a circular lumen126 to engage a locking mechanism140 (shown inFIGS. 48-51) and a slit127. A section of the lockingteeth138 is shown which is designed to engage a ratchet tap thelocking mechanism140. The locking mechanism engages the teeth in the strap and the surface of the strap head at the rectangular slot. The circular lumen is to fix the mesh and control element during expansion or contraction of the strap (thread onto the fill tube) and to allow access into the mesh annular space or inner circular region—donut hole (through the fill tube.
• Suitable non-degradable materials for the lockingstrap control element128 include, but are not limited to, Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluroethylene (e-PTFE), polyetheretherketone (PEEK), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) commercially available as Spectral or Dyneema™, as well as other high tensile strength materials such as Vectran™, Kevlar™, natural or artificially produced silk and commercially available suture materials used in a variety of surgical procedures.
• FIG. 47 is a magnified perspective side view of the second type of lockingstrap control element128 of the present invention comprised of anon-locking head132 attached to anelongated strap130.FIG. 47 shows that, in this embodiment, thehead132 and strap are substantially planar in shape and thereby providing a low profile. The Applicants contemplate that other profiles may be employed in the present invention, e.g. oval or circular, or a combination of shapes, such as a circular head attached to a planar strap, could be used as the control element for the present invention. ThisFIG. 47 further shows thelocking gear teeth138 located on one side of thestrap130.
• FIG. 48 is a side cross-sectional view of thelocking mechanism140 for the second type of lockingstrap control element128 of the present invention. Thelocking mechanism140 is substantially cylindrical in shape and generally includes an internalluminal area142 and with awall thickness144.
• Suitable non-degradable materials for thelocking mechanism140 include, but are not limited to, Nylon, Dacron, synthetic polyamide, polypropylene, expanded polytetrafluroethylene (e-PTFE), polyetheretherketone (PEEK), polyethylene and ultra-high molecular weight fibers of polyethylene (UHMWPE) commercially available as Spectral or Dyneema™, as well as other high tensile strength materials such as Vectran™, Kevlar™, natural or artificially produced silk and commercially available suture materials used in a variety of surgical procedures.
• FIG. 49 is a front view of thelocking mechanism140 for the second type of lockingstrap control element128 of the present invention. ThisFIG. 49 shows in more detail the orientation of the internal structures and ratchet tab orpall134.
• FIG. 50 is an isometric view of thelocking mechanism140 for the second type of lockingstrap control element128 of the present invention. ThisFIG. 50 also shows the ratchet tab orpall134 and a outside surface having a stepped pattern with a firstlarger diameter136 and a secondsmaller diameter135 designed to engage the a locking mechanism delivery and cutoff system (not shown).
• FIG. 51 is a side cross-sectional view of thelocking mechanism140 for the second type of lockingstrap control element128 of the present invention showing a section plane across the ratchet tab orpall134 and having a internalluminal area142.
• It should be understood that the foregoing description of the present invention is intended merely to be illustrative thereof and that other embodiments, modifications, and equivalents of the invention are within the scope of the invention recited in the claims appended hereto. Further, although each embodiment described above includes certain features, the invention is not limited in this respect. Thus, one or more of the above-described or other features of the invention, method of delivery, or injection of biomaterial may be employed singularly or in any suitable combination, as the present invention is not limited to a specific embodiment.

Claims (107)

1. A method of treating a diseased inter-vertebral disc, comprising the steps of:

creating an access opening in a disc between the adjacent vertebrae;

removing at least a portion of a nucleus within said disc which results in forming a cavity surround by an annulus of said disc;

advancing into said cavity an expandable mesh with a control element apparatus;

expanding said expandable mesh using said control element within the limits of a inside surface of said annulus creating a deployed expandable mesh wherein said expandable mesh has an autologous configuration; said expandable mesh having an inner chamber and an inner central hole;

delivering and injecting said chamber with a first biocompatible material resulting in a substantially filled expandable mesh, and

delivering and injecting said inner central hole with a second biocompatible material resulting in a substantially filled central hole.

2. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said first biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

3. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said first biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

4. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said first biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

5. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said first biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

6. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said first biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

7. The method of treating a diseased inter-vertebral disc as recited inclaim 6, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

8. The method of treating a diseased inter-vertebral disc as recited inclaim 6, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

9. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said second biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

10. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said second biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

11. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said second biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

12. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said second biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

13. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said second biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

14. The method of treating a diseased inter-vertebral disc as recited inclaim 13, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

15. The method of treating a diseased inter-vertebral disc as recited inclaim 13, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

16. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

17. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

18. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc height is achieved.

19. The method of treating a diseased inter-vertebral disc as recited inclaim 1, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc pressure is achieved.

20. The method of treating a diseased inter-vertebral disc as recited inclaim 1, after the step of expanding said expandable mesh using said control element within the limits of a inside surface of said annulus creating a deployed expandable mesh wherein said expandable mesh has an autologous configuration; said expandable mesh having an inner chamber and an inner central hole; further comprising:

contracting said control element whereby said inner central hole attains a desired diameter.

22. The method of treating a diseased inter-vertebral disc as recited inclaim 1, after the step of delivering and injecting said second biocompatible material; further comprising:

securing said control element with a locking mechanism to maintain the integrity of said substantially filled central hole within said diseased vertebral disc.

23. The method of treating a diseased inter-vertebral disc as recited inclaim 1, whereby said substantially filled central hole results in a circular concavo-concave configuration.

24. A method of treating a diseased inter-vertebral disc, comprising the steps of:

creating an access opening in a disc between the adjacent vertebrae;

removing at least a portion of an annulus within said disc which results in forming a cavity surrounding the nucleus of said disc;

advancing into said cavity an expandable mesh and a control element at least partially encircling said annular cavity;

expanding said expandable mesh using said control element within the limits of the outside surface of said annulus cavity creating a deployed expandable mesh wherein said expandable mesh has an autologous configuration and an inner chamber; and

delivery and injecting said chamber with a biocompatible material resulting in a filled expandable mesh.

25. The method of treating a diseased inter-vertebral disc as recited inclaim 24, wherein said biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

26. The method of treating a diseased inter-vertebral disc as recited inclaim 24, wherein said biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

27. The method of treating a diseased inter-vertebral disc as recited inclaim 24, wherein said biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

28. The method of treating a diseased inter-vertebral disc as recited inclaim 24, wherein said biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

29. The method of treating a diseased inter-vertebral disc as recited inclaim 24, wherein said biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

30. The method of treating a diseased inter-vertebral disc as recited inclaim 29, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

31. The method of treating a diseased inter-vertebral disc as recited inclaim 29, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

32. The method of treating a diseased inter-vertebral disc as recited inclaim 24, after the step of expanding said expandable mesh using said control element within the limits of a inside surface of said annulus creating a deployed expandable mesh wherein said expandable mesh has an autologous configuration; said expandable mesh having an inner chamber and an inner central hole; further comprising:

contracting said control element whereby said inner central hole attains a desired diameter.

33. The method of treating a diseased inter-vertebral disc as recited inclaim 24, after the step of delivering and injecting said second biocompatible material; further comprising:

securing said control said control element with a locking mechanism to maintain the integrity of said filled expandable mesh within said diseased vertebral disc.

34. The method of treating a diseased inter-vertebral disc as recited inclaim 24, whereby said filled expandable mesh results in a concavo-concave configuration.

35. A method of treating a diseased vertebrae disc, comprising the steps of:

creating an access opening in a disc between the adjacent vertebrae;

removing the annulus and the nucleus within said disc which results in forming a cavity surround by an inner surface of said disc;

advancing into said cavity an expandable mesh and a control element;

expanding said expandable mesh using said control element within the limits of the outer surface of said annulus thereby creating a deployed expandable mesh wherein said expandable mesh has an autologous configuration; said expandable mesh having an inner chamber and an inner central hole;

delivering and injecting said inner chamber with a first biocompatible material resulting in a substantially filled expandable mesh; and

delivering and injecting said inner central hole with a second biocompatible material, resulting in a substantially filled central hole.

36. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said first biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

37. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said first biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

38. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said first biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

39. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said first biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

40. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said first biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

41. The method of treating a diseased inter-vertebral disc as recited inclaim 40, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HP₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄₀.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

42. The method of treating a diseased inter-vertebral disc as recited inclaim 40, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

43. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said second biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

44. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said second biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

45. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said second biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

46. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said second biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

47. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said second biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)20).

48. The method of treating a diseased inter-vertebral disc as recited inclaim 47, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

49. The method of treating a diseased inter-vertebral disc as recited inclaim 47, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

50. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

51. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

52. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc height is achieved.

53. The method of treating a diseased inter-vertebral disc as recited inclaim 35, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc pressure is achieved.

54. The method of treating a diseased inter-vertebral disc as recited inclaim 35, after the step of expanding said expandable mesh using said control element within the limits of a inside surface of said annulus creating a deployed expandable mesh wherein said expandable mesh has an autologous configuration; said expandable mesh having an inner chamber and an inner central hole; further comprising:

contracting said control element whereby said inner central hole attains a desired diameter.

55. The method of treating a diseased inter-vertebral disc as recited inclaim 35, after delivering and injecting said second biocompatible material; further comprising:

securing said control said control element with a locking mechanism to maintain the integrity of said substantially filled central hole within said diseased vertebral disc.

56. The method of treating a diseased inter-vertebral disc as recited inclaim 35, whereby said substantially filled central hole results in a circular concavo-concave configuration.

57. A method of treating a diseased inter-vertebral disc, comprising the steps of:

creating an access opening in a disc between the adjacent vertebrae;

removing the nucleus within said disc which results in forming a cavity surround by an annulus of said disc;

advancing into said cavity an expandable mesh and a control element;

expanding said expandable mesh using said control element wherein said expandable mesh has an adjustable configuration; said expandable mesh having an adjustable inner chamber and an adjustable inner central hole;

using the control element to adjust the expandable mesh to expand within the limits of the outside was of the annulus and to create an adjustable diameter inner central hole, creating a deployed expandable mesh;

delivering and injecting said adjustable chamber with a first biocompatible material resulting in a first filled expandable mesh; and

delivering and injecting said adjustable inner central hole with a second biocompatible material, resulting in a substantially filled central hole.

58. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said first biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

59. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said first biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

60. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said first biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

61. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said first biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

62. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said first biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

63. The method of treating a diseased inter-vertebral disc as recited inclaim 62, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

64. The method of treating a diseased inter-vertebral disc as recited inclaim 62, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

65. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said second biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

66. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said second biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

67. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said second biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

68. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said second biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

69. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said second biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

70. The method of treating a diseased inter-vertebral disc as recited inclaim 69, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

71. The method of treating a diseased inter-vertebral disc as recited inclaim 69, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

72. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

73. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

74. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc height is achieved.

75. The method of treating a diseased inter-vertebral disc as recited inclaim 57, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc pressure is achieved.

76. The method of treating a diseased inter-vertebral disc as recited inclaim 57, after expanding said expandable mesh using said control element within the limits of a inside surface of said annulus creating a deployed expandable mesh wherein said expandable mesh has an adjustable configuration; said expandable mesh having an inner chamber and an inner central hole; further comprising:

contracting said control element whereby said inner central hole attains a desired diameter.

77. The method of treating a diseased inter-vertebral disc as recited inclaim 57, after delivering and injecting said second biocompatible material; further comprising:

securing said control said control element with a locking nut to maintain the integrity of said substantially filled central hole within said diseased vertebral disc.

78. The method of treating a diseased inter-vertebral disc as recited inclaim 57, whereby said substantially filled central hole results in a circular concavo-concave configuration.

79. A method of treating a diseased inter-vertebral disc, comprising the steps of:

creating an access opening in a disc between the adjacent vertebrae;

removing the annulus within said disc which results in forming a cavity surrounding the nucleus of said disc;

advancing into said cavity an expandable mesh and a control element;

expanding said expandable mesh using said control element creating a deployed expandable mesh wherein said expandable mesh has an adjustable configuration;

using the control element to adjust the expandable mesh to expand within the limits of the outside wall of the annulus; and

delivering and injecting said adjustable chamber with a biocompatible material, resulting in a filled expandable mesh.

80. The method of treating a diseased inter-vertebral disc as recited inclaim 79, wherein said biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

81. The method of treating a diseased inter-vertebral disc as recited inclaim 79, wherein said biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

82. The method of treating a diseased inter-vertebral disc as recited inclaim 79, wherein said biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

83. The method of treating a diseased inter-vertebral disc as recited inclaim 79, wherein said biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers, polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

84. The method of treating a diseased inter-vertebral disc as recited inclaim 79, wherein said first biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

85. The method of treating a diseased inter-vertebral disc as recited inclaim 84, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂: SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

86. The method of treating a diseased inter-vertebral disc as recited inclaim 84, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

87. The method of treating a diseased inter-vertebral disc as recited inclaim 79, after the step of expanding said expandable mesh using said control element within the limits of a inside surface of said annulus creating a deployed expandable mesh wherein said expandable mesh has an adjustable configuration; said expandable mesh having an inner chamber and an inner central hole; further comprising:

contracting said control element whereby said inner central hole attains a desired diameter.

88. The method of treating a diseased inter-vertebral disc as recited inclaim 79, after the step of delivering and injecting said second biocompatible material; further comprising:

securing said control said control element with a locking nut to maintain the integrity of said filled expandable mesh within said diseased vertebral disc.

89. The method of treating a diseased inter-vertebral disc as recited inclaim 79, whereby said filled expandable mesh results in a circular concavo-concave configuration.

90. A method for repairing diseased vertebrae, comprising the steps of:

creating an access opening in a disc between the adjacent vertebrae;

removing the annulus and the nucleus within said disc which results in forming a cavity surround by an inner surface of said disc;

advancing into said cavity an expandable mesh and a control element;

expanding said expandable mesh using said control element wherein said expandable mesh has an adjustable configuration; said expandable mesh having an adjustable inner chamber and an adjustable inner central hole;

delivering and injecting said adjustable chamber with a first biocompatible material, resulting in a first filled expandable mesh; and

delivering and injecting said adjustable inner central hole with a second biocompatible material, resulting in a substantially filled central hole.

91. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said first biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

92. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said first biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

93. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said first biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

94. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said first biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers,_polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

95. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said second biocompatible material is formed of a material selected from the group consisting of hydrophilic polymers, hydrogels, homopolymer hydrogels, copolymer hydrogels, multi-polymer hydrogels, or interpenetrating hydrogels, acrylonitrile, acrylic acid, acrylimide, acrylimidine, including but not limited to PVA, PVP, PHEMA, PNVP, polyacrylainides, poly(ethylene oxide), polyvinyl alcohol, polyarylonitrile, and polyvinyl pyrrolidone, silicone, polyurethanes, polycarbonate-polyurethane (e.g., Corethane) other biocompatibile polymers, or combinations thereof.

96. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said second biocompatible material is formed of a material that is allowed to expand through the adsorption of liquids such as water selected from the group consisting of polyacrliamide, polyacrylonitrile, polyvinyl alcohol or other biocompatible hydrogels, solid fibrous collagen or other suitable hydrophilic biocompatible material or combinations thereof.

97. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said second biocompatible material is formed of a material selected from the group consisting of steroids, antibiotics, tissue necrosis factor alpha or its antagonists, analgesics, growth factors, genes or gene vectors in solution; biologic materials (hyaluronic acid, non-crosslinked collagen, fibrin, liquid fat or oils); synthetic polymers (polyethylene glycol, liquid silicones, synthetic oils), saline or combinations thereof.

98. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said second biocompatible material is formed of a material selected from the group consisting of bone graft materials such as any described “bone cements” or any polymeric bone graft compounds, bone graft materials, bone chips, nylon fibers, carbon fibers, glass fibers, collagen fibers, ceramic fibers, polyethylene fibers,_polypropylene fibers, poly(ethylene terephthalate), polyglycolides, polylactides, and combinations thereof.

99. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said second biocompatible material is formed from calcium phosphate-based bone substitutes such as monolithic tetracalcium phosphate (CA₄(PO₄)₂O).

100. The method of treating a diseased inter-vertebral disc as recited inclaim 99, further comprising minor amounts of additional substances, such as Na₃PO₄; Na₂HPO₄; NaH₂PO₄; Na₄HPO₄.7H₂O; Na₃PO₄.12H₂O; H₃PO₄; CaSO₄; (NH₄)₃PO₄; (NH₄)₂HPO₄; (NH₄)H₂PO₄; (NH₄)₃PO₄.3H₂O; NaHCO₃; CaCO3; Na₂CO₃; KH₂PO₄; K₂HPO₄; K₃PO₄; CaF₂:SrF₂; Na₂SiF₆; Na₂PO₃F, and combinations thereof.

101. The method of treating a diseased inter-vertebral disc as recited inclaim 99, further comprising an amount of one or more active agents suitable to promote bone growth, such as a growth factor, BMP, a bone morphology protein, or a pharmaceutical carrier, and combination thereof.

102. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said spinal disc device is adapted to promote spinal fixation between two adjacent vertebral bodies.

103. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said spinal disc device is deformable to conform to an interior region of a vertebral disc.

104. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc height is achieved.

105. The method of treating a diseased inter-vertebral disc as recited inclaim 90, wherein said spinal disc device is adapted to inject a volume of biocompatible material into said inner central area of said expandable mesh until a desired disc pressure is achieved.

106. The method of treating a diseased inter-vertebral disc as recited inclaim 90, after the step of expanding said expandable mesh using said control element within the limits of a inside surface of said annulus creating a deployed expandable mesh wherein said expandable mesh has an adjustable configuration; said expandable mesh having an inner chamber and an inner central hole; further comprising:

contracting said control element whereby said inner central hole attains a desired diameter.

107. The method of treating a diseased inter-vertebral disc as recited inclaim 90, after the step of delivering and injecting said second biocompatible material further comprising:

securing said control said control element with a locking mechanism to maintain the integrity of said substantially filled central hole within said diseased vertebral disc.

108. The method of treating a diseased inter-vertebral disc as recited inclaim 90, whereby said substantially filled central hole results in a circular concavo-concave configuration.

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